ALMOTRIPTAN 12.5 mg Tabletki powlekane
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Jak stosować ALMOTRIPTAN TEVA ITALIA
Treść ulotki
Almotriptan Teva Italia 12,5 mg film-coated tablets
Generic medicine
Read this leaflet carefully before you start taking this medicine as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet
- 1. What Almotriptan Teva Italia is and what it is used for
- 2. What you need to know before you take Almotriptan Teva Italia
- 3. How to take Almotriptan Teva Italia
- 4. Possible side effects
- 5. How to store Almotriptan Teva Italia
- 6. Contents of the pack and other information
1. What is Almotriptan Teva Italia and what is it used for
Almotriptan Teva Italia is an anti-migraine agent belonging to the class of drugs
known as selective serotonin receptor agonists. It is believed that Almotriptan
Teva Italia reduces the inflammatory response associated with migraine, by binding to
serotonin receptors in the brain (cranial) blood vessels, causing their constriction.
Almotriptan Teva Italia is used to relieve headache associated with migraine attacks
with or without aura
2. What you need to know before taking Almotriptan Teva Italia
Do not take Almotriptan Teva Italia:
- if you are allergic to Almotriptan Teva Italia or to any of the ingredients of this medicine (listed in section 6).
- if you suffer from or have suffered from diseases that limit blood flow to the heart such as:
- heart attack
- chest pain or discomfort that typically occurs with physical activity or stress
- heart problems without pain
- chest pain that occurs at rest
- severe hypertension (severely elevated blood pressure)
- mild or moderate uncontrolled high blood pressure
- if you have had a stroke or a reduction in blood flow to the brain
- if you have had a blockage of the major arteries in the arms or legs (peripheral vascular disease)
- if you are taking other medicines used to treat migraines including ergotamine, dihydroergotamine and metisergide or other serotonin agonists (e.g. sumatriptan)
- if you suffer from a severeliver disease.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Almotriptan Teva Italia:
- if your type of migraine has not been diagnosed
- if you are allergic (hypersensitive) to antibacterial medicines commonly used for the treatment of urinary tract infections (sulfonamides)
- if the symptoms of your headache are different from your usual attacks, for example if you experience noise in your ears or dizziness, if you have a brief paralysis of one side of your body or paralysis of the muscles that control eye movement, or if new symptoms appear
- if you are at risk of heart disease, including high and uncontrolled blood pressure, high cholesterol, obesity, diabetes, smoking, a confirmed family history of heart disease or if you are a postmenopausal woman or if you are a man over 40 years of age.
- if you have mild or moderate liver disease
- if you have a severekidney disease
- if you are over 65 years of age (because you are more likely to have increases in blood pressure)
- if you are taking antidepressant SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin and noradrenaline reuptake inhibitors) See also the section below “Other medicines and Almotriptan Teva Italia”.
It has been suggested that excessive use of anti-migraine drugs can lead to chronic daily headache.
Children and adolescents
Children under the age of 18 should not take Almotriptan Teva Italia.
Elderly (over 65 years)
If you are over 65 years old, contact your doctor before using this medicine.
Other medicines and Almotriptan Teva Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Tell your doctor:
- if you are taking medicines used to treat depression such as monoamine oxidase inhibitors (e.g. moclobemide), selective serotonin reuptake inhibitors (e.g. fluoxetine) or serotonin and noradrenaline reuptake inhibitors (e.g. venlafaxine), as they can cause serotonin syndrome, a potentially life-threatening adverse drug reaction. Symptoms of serotonin syndrome include: confusion, restlessness, fever, sweating, uncoordinated movements of the limbs or eyes, uncontrollable muscle spasms or diarrhea
- if you are taking St. John's Wort (Hypericum perforatum) preparations as it may increase the possibility of side effects.
Almotriptan should not be taken at the same time as medicines containing
ergotamine, also used for the treatment of migraine. However, these medicines
can be taken one after the other provided that an adequate period of time has elapsed between taking each medicine:
- after taking almotriptan, it is recommended to wait at least 6 hours before taking ergotamine
- after taking ergotamine, it is recommended to wait at least 24 hours before taking almotriptan.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
Only limited data are available on the use of Almotriptan Teva Italia in pregnant
women. During pregnancy, Almotriptan should only be used if prescribed by
your doctor and only after carefully assessing the benefits and risks.
Caution should be exercised when using this medicine during breastfeeding.
Breastfeeding should be avoided for 24 hours after taking the
medicine.
Driving and using machines
Almotriptan Teva Italia can cause drowsiness. If you experience this symptom, you should not drive
vehicles or use tools or machinery.
3. How to take Almotriptan Teva Italia
Almotriptan Teva Italia must be used only to treat an ongoing migraine attack and not to prevent migraine or headache attacks.
Take this medicine following the instructions of your doctor exactly. If you have any doubts,
consult your doctor or pharmacist.
Adults (18-65 years)
The recommended dose is one 12.5 mg tablet, which should be taken as soon as
possible after the onset of the migraine attack. If the migraine does not subside, do not
take more than one tablet for the same attack.
If a second migraine attack occurs within 24 hours, a second 12.5 mg tablet may be taken, but you must wait at leasttwo hours between the
first and second tablet.
The maximum daily dose is two tablets (12.5 mg) within 24 hours.
The tablets should be swallowed with liquid (e.g. water) and can be taken with or
without food.
You should take Almotriptan Teva Italia as soon as possible after the onset of the migraine,
although the medicine is also effective if used at a more advanced stage.
Severe kidney disease
If you suffer from severe kidney disease, do not take more than one 12.5 mg tablet within 24
hours.
If you take more Almotriptan Teva Italia than you should
If you accidentally take too many tablets, or if another person or a child takes your
medicine, seek immediate medical or pharmaceutical advice.
If you forget to take Almotriptan Teva Italia
Try to take Almotriptan Teva Italia as prescribed. Do not take a double dose to make up for a missed tablet.
If you have any doubts about using this medicine, consult your doctor, pharmacist or
nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects(may affect up to 1 in 10 people)
- dizziness
- insomnia (drowsiness)
- nausea
- vomiting
- fatigue Uncommon side effects(may affect up to 1 in 100):
- tingling, prickling or numbness of the skin (paresthesia)
- headache
- ringing, roaring or clicking in the ears (tinnitus)
- strong heartbeat (palpitations)
- tightness in the throat
- diarrhea
- digestive difficulties (dyspepsia)
- dry mouth
- muscle pain (myalgia)
- bone pain
- chest pain
- weakness (asthenia) Very rare side effects(may affect up to 1 in 10,000)
- spasm of the heart vessels (coronary vasospasm)
- heart attack (myocardial infarction)
- increased heart rate (tachycardia)
Frequency not known (the frequency cannot be estimated from the available data)
- allergic reactions (hypersensitivity reactions), including swelling of the mouth, throat or hand (angioedema)
- severe allergic reactions (anaphylactic reactions)
- convulsions (seizures)
- impaired vision, blurred vision (visual disturbances may also occur during a migraine attack)
- intestinal vasospasm, which can cause damage to the intestine (intestinal ischemia). This may be accompanied by abdominal pain and bloody diarrhea. During treatment with Almotriptan, inform your doctor immediately:
- if you experience chest pain, a feeling of pressure in the chest or throat, or any other symptoms that may seem like a heart attack. Inform your doctor immediately and do not take any more Almotriptan tablets
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side
effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Almotriptan Teva Italia
Keep this medicine out of the sight and reach of children .
Do not use this medicine after the expiry date which is stated on the blister and the carton
after SCAD. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Almotriptan Teva Italia contains
The active ingredient is almotriptan 12.5 mg (as almotriptan D,L-hydrogen maleate).
The other ingredients are:
Tablet core: mannitol, microcrystalline cellulose, povidone, sodium starch glycolate (Type A), sodium stearylfumarate.
Coating: hypromellose, titanium dioxide (E-171), macrogol 400.
Description of the appearance of Almotriptan Teva Italia and contents of the pack
Almotriptan Teva Italia is available as film-coated tablets, white, round,
biconvex, smooth.
Almotriptan Teva Italia is available in blister packs containing 3, 4, 6, 9 or 12
tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. , Piazzale Luigi Cadorna, 4 - 20123 Milan
Manufacturer
SAG Manufacturing, S.L.U.
Ctra N-I, Km 36, San Agustin de Guadalix
28750 Madrid
Spain
Galenicum Health, S.L.
Avda Cornella 144, 7°-1 Edificio Lekla
Esplugues de Llobregat
08950 Barcelona
Spain
STE Pharma System, S.L.
Avda. Universitat Autónoma, 13,
Parc Tecnológic del Vallés,
Cerdanyola del Vallés,
08290 Barcelona
Spain
INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.
C/laguna 66-68-70, Pol. Industrial Urtinsa II,
Alcorcón, 28923 Madrid
Spain
This medicinal product is authorised in the Member States of the European Economic Area
under the following denominations:
| Portugal | Almotriptano Galenicum, 12.5 mg comprimido revestido por película |
| United Kingdom | Almotriptan Galenicum 12.5 mg film-coated tablets |
| Spain | Almotriptan VIR 12,5 mg comprimidos recubiertos con película |
| France | Almotriptan Biogaran 12,5 mg, comprimé pelliculé |
| Italy | Almotriptan Teva Italia |
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- Kraj rejestracji
- Postać farmaceutycznaFilm-coated tablet, 12.5 MG
- Kod ATCN02CC05
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki ALMOTRIPTAN TEVA ITALIAPostać farmaceutyczna: Film-coated tablet, 12,5 MGSubstancja czynna: almotriptanProducent: ALMIRALL S.A.Wymaga receptyPostać farmaceutyczna: Film-coated tablet, 12.5 MGSubstancja czynna: almotriptanProducent: DOC GENERICI SRLWymaga receptyPostać farmaceutyczna: Film-coated tablet, 12.5 MGSubstancja czynna: almotriptanProducent: MYLAN S.P.A.Wymaga recepty
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ALMOTRIPTAN TEVA ITALIA wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w ALMOTRIPTAN TEVA ITALIA jest almotriptan. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
ALMOTRIPTAN TEVA ITALIA jest produkowany przez TEVA ITALIA S.R.L.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie ALMOTRIPTAN TEVA ITALIA jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić ALMOTRIPTAN TEVA ITALIA w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (almotriptan) to m.in. ALMOTREX, ALMOTRIPTAN DOK JENERIKI, ALMOTRIPTAN MYLAN. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
